Compassionate Use Re-Infusion of ATLCAR.CD30

This is an expanded access trial for Hodgkin Lymphoma, Adult Read More

Inclusion Criteria:

• Karnofsky or Lansky score of >60%.
• WOCBP must be willing to use 2 methods of birth control or be surgically sterile , or abstain from heterosexual activity for the course of the study, or for 6 months after the study is concluded. WOCBP are those who have not been surgically sterilized or have not been free from menses for > 1 year. The two birth control methods can be composed of: two barrier methods or a barrier method plus a hormonal method to prevent pregnancy. WOCBP subjects will also be instructed to tell their male partners to use a condom.
• Must not be pregnant or lactating.
• Must not have tumor in a location where enlargement could cause airway obstruction.
• Must not have current use of systemic corticosteroids at doses ≥10 mg prednisone daily or its equivalent; those receiving <10mg daily may be enrolled at discretion of the Investigator

• Evidence of adequate organ function as defined by:

  • ANC>1.0 × 109/L
  • Platelets >75 × 109/L
  • Total bilirubin ≤2 × ULN, unless attributed to Gilbert's syndrome
  • AST ≤3 × ULN
  • Serum creatinine ≤1.5 × ULN
  • Pulse oximetry of >90% on room air Note: Patient may receive a second infusion without prior lymphodepletion if they meet the eligibility criteria in this Sections 3.1 and 3.2 at the time of infusion, but do not meet the eligibility requirements for adequate bone marrow function and platelet counts
• Negative serum pregnancy test within 72 hours prior to lymphodepletion or documentation that the patient is post-menopausal. Post-menopausal status must be confirmed with documentation of absence of menses for > 1 year or documentation of surgical menopause involving bilateral oophorectomy.
• Patient cannot be on strong inhibitors of CYP1A2 (e.g., fluvoxamine, ciprofloxacin) as these may increase plasma concentrations of bendamustine, and decrease plasma concentrations of its metabolites. See http://medicine.iupui.edu/clinpharm/ddis/ for an updated list of strong inhibitors of CYP1A2. (This applies to subjects who receive bendamustine for lymphodepletion (required) up through 72 hours after the last dose of bendamustine)
• Patient is a good candidate for treatment with ATLCAR.CD30 per the investigator's discretion.

Exclusion Criteria:

• No evidence of uncontrolled infection or sepsis.

• Evidence of adequate organ function as defined by:

  • Total bilirubin ≤2 × ULN, unless attributed to Gilbert's syndrome
  • AST ≤3 × ULN
  • ALT ≤3 × ULN
  • Serum creatinine ≤1.5 × ULN
  • Pulse oximetry of >90% on room air
• Patient has no clinical indication of rapidly progressing disease in the opinion of the treating physician
• Patient is a good candidate for treatment with ATLCAR.CD30 per the investigator's discretion.
• If Patient has had positive hepatitis B core antibody testing while on the LCCC 1532-ATL clinical trial, they must not have had re-activation of the Hepatitis B virus since baseline testing (i.e., they will be excluded if any of their hepatitis B viral load testing is positive up until the point of eligibility determination for re-infusion).